Observational Study in HCV Chronic Infection

Hepatitis C, Chronic Clinical Trial

Official title:

Prospective Multicentric Observational Study in HCV Chronic Infected Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945008
• Other study ID #: PITER 01
• Status: Completed
• Start date: April 2014
• Est. completion date: November 2015

Study information

• Verified date: April 2020
• Source: Istituto Superiore di Sanità
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

HCV infection is the most frequent cause of liver chronic disease, cirrhosis and hepatocellular carcinoma in western countries.

To date, the standard antiviral treatment, including pegylated interferon (PEG-IFN) plus ribavirin (RBV), has relatively low effectiveness in patients infected with genotype 1 and 4, and is associated with important adverse side effects, that lead to treatment interruption in approximately 30% of cases.

The recent association of first generation HCV- specific direct-acting antiviral agents (DAAs) (telaprevir and boceprevir) to standard treatment has resulted in higher SVR rates, also in patients infected with genotype-1 HCV and in non responders to PEG-IFN plus RBV. While several new DAAs are in development, the ultimate goal is represented by IFN-free regimens, that will provide a great advantage in terms of patients adherence to therapy and quality of life.

In this context, prospective observational studies are needed to evaluate the real and long-term impact of the new DAAs in the clinical practice, in terms of efficacy, safety, costs and impact on patients quality of life.

Italy is the European country with the greatest number of HCV infected people (average, 3% of population), with higher prevalence in the center and in the south of the country, especially in older individuals, and the highest mortality caused by hepatocellular carcinoma. Genotype 1 is the most frequent one (in more than 50% of infected people). DAAs were approved at the end of 2012. For these reasons, Italy represents an interesting context for collecting data on long-term efficacy, safety and tolerability of new anti-HCV treatments.

The PITER cohort study, developed in the frame of Italian Platform for the study of the therapy of viral hepatitis a prospective observational study, is based on a large cohort of HCV infected patients from more than 100 clinical centers distributed on the whole national area.

The main aims of the PITER longitudinal cohort study are: 1) to produce of an ongoing and continuously updated picture of the changing epidemiology of HCV infection in the country; 2) to evaluate in a real-life setting the expected impact of DAAs on the natural course of infection and on long-term morbidity and mortality.

Description:

Collected data will include clinical, laboratory and anatomopathological information and will be recorded in electronic CRF, at the enrollment and follow-up visits.

Special attention will be devoted to specific patient categories (with HIV, HBV, HDV and HEV coinfections, comorbidities, disease patients who presents signs of liver disease progression). Subjects starting an antiviral regimen will be followed according to specific guidelines.

A sub-study on quality of life/adherence to treatment/treatment satisfaction will be also conducted on all treated patients of the cohort.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7600
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All HCV infected patients who will consecutively come to the participating clinical centers in a given time span (enrollment periods)

Exclusion Criteria:

• Younger than 18 years

• Patients treated at the moment of the enrollment

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C, Chronic

Locations

Country	Name	City	State
Italy	Istituto Superiore di Sanità	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Superiore di Sanità

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age distribution at recruitment	Age distribution will be expressed in years and reported as median	ten years
Primary	Sex distribution at recruitment	The sex distribution (males and females) will be reported as frequencies (percent)	ten years
Primary	BMI distribution at recruitment	The BMI (kg/m^2) will be expressed in the following cathegories: Underweight, Normal, Overweight, Obese and will be reported as frequencies (percent)	ten years
Primary	Genotype distribution at recruitment	Genotype distribution will be expressed in the following categories: 1 non subtyped, 1a, 1b, 2, 3, 4-5, and will be reported as frequencies (percent)	ten years
Primary	Liver disease stage at recruitment	The liver disease stage distribution will be expressed in the following chategories: F0-F3, F4-cirrhosis, decompensated cirrhosis, HCC, liver transplant, and will be reported as frequencies (percent)	ten years
Primary	Sustained virological response (SVR) in treated patients	Rates of SVR for each expected combination of DAAs used; identification of factors influencing HCV treatment response in the real life.	ten years
Primary	Changes in the severity of liver disease	Changes in liver function will be evaluated in terms of Child Pugh (C-P) score increase or decrease by 1 or more points, whatever occurred first after the end of treatment.; This outcome will be expressed as proportions (percent)	ten years
Primary	Incidence of Hepatocellular carcinoma (HCC)	Incidence of HCC will be evaluated on the basis of the first diagnosis reported after the end of treatment, excluding prevalent HCC cases occurred before treatment.; Cumulative incidence will be expressed as proportions (percent)	ten years
Primary	Incidence and recurrence of decompensated cirrhosis	Liver decompensating event is defined as the presence or appearance of ascites and/or portal hypertensive gastrointestinal bleeding and/or hepatic encephalopathy.; Incidence of a decompensating event will be evaluated on the basis of the first occurrence after the end of treatment, excluding cases occurred before treatment.; Recurrence of decompensation will be evaluated on the basis of the first events in patients with previous history of decompensated cirrhosis.; Cumulative incidence or recurrence will be expressed as proportions (percent)	ten years